Felbamate

Felbatol (FEL-bah-tol) is the brand name used in the United States for the seizure medicine felbamate (FEL-bah-mate). Felbamate is not available in Canada, the UK, or Australia. It is available in some European countries using the name Taloxa (marketed by Schering Plough).

Felbatol is not available in generic (non-brand) form in the United States.

Felbatol

Tablet

400-mg (yellow, scored, capsule-shaped)

600-mg (peach-colored, scored, capsule-shaped)

Liquid Solution

600 mg/5 mL peach-colored liquid

Used to treat

Lennox-Gastaut Syndrome

Temporal Lobe Epilepsy

Atonic Seizures

Focal Impaired Awareness or Complex Partial Seizures

Refractory Seizures

Secondarily Generalized Seizures or Bilateral Tonic Clonic Seizure

Focal Aware or Simple Partial Seizure

Tonic-clonic Seizures

Forms

Felbatol is marketed in the United States by Medpointe Pharmaceuticals. The name or appearance may differ in other places. The dose (measured in milligrams, abbreviated "mg") will usually be the same. These descriptions apply to the U.S. versions:

Dosing

See package insert.

How to take and store Felbamate?

Follow your doctor's directions. Call if you have any questions. Usually, your doctor will tell you to start by taking 600 to 1200 milligrams (mg) total per day. The doctor will probably recommend taking a part of this dose at three or four different times each day. A similar dose for children is 15 mg per kilogram (2.2 pounds) of the child's weight. After a week or two, larger doses probably will be prescribed to get better control of seizures. If other seizure medicines are being used at the same time, you may be told to use smaller amounts of them. Be sure to follow the doctor's instructions carefully. Ask the doctor what to do if you forget a dose.

Felbatol can be taken either with food or without food.

If you are using the suspension (liquid), shake the bottle well immediately before measuring it. Use the same standard-size measuring spoon or dropper each time so the dose will be correct. Store the bottle at room temperature and keep it out of the reach of children.

Be careful if the doctor writes a new prescription using a different kind of pill. For example, if you've been using 400-mg tablets and the new prescription is for 600-mg tablets, be careful to use the correct number. Don't automatically continue to use the same number of pills as before. Make sure you know what size tablet has been prescribed.

Don't take more than the doctor prescribes. Be sure to use only the amount of Felbatol that your doctor prescribes. If you think you've taken one or two extra tablets, or an extra teaspoon of liquid, call your doctor for advice. For a larger overdose, call your local poison control center or emergency room right away, unless you have special directions from the doctor. There have been no reports of serious harm resulting from an overdose of Felbatol, however.

Don't stop using Felbatol or change the amount taken without talking to the doctor first. Stopping any seizure medicine all at once can cause a serious problem called status epilepticus.

All forms of Felbatol should be stored at room temperature, away from light and humidity. (Don't keep the pills in the bathroom if it's damp there.) Of course, keep all Felbatol out of the reach of children.

What if I forget?

If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, delay that dose for a few hours instead of taking two doses very close together. Then go back to the regular schedule. If you're not sure about what to do, call the doctor's office for more advice.

Do your best to follow the doctor's directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

How does Felbamate affect the brain?

Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Felbatol helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.

How does the body digest Felbamate?

After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing, digesting, and excreting a medicine or food is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by liver disease or kidney disease.

Felbatol is broken down (digested) in the liver. People with liver disease must be cautious about taking it. Other people also need to be careful if they take other medicines that are digested in the liver, as many are. The metabolism of each medicine may be affected, changing how quickly it works and leaves the body.

This is why the doctor needs to know about everything that a person takes—prescription medicines, over-the-counter medications, vitamins and other dietary supplements, and herbs. In most cases, all the medicines can be used if the amounts are adjusted to allow for these changes.

Felbatol is eliminated from the body in the urine, produced by the kidneys.

How well does the Felbamate work?

Because of concerns that Felbatol increases the risk of a few rare but serious and potentially life-threatening disorders, Felbatol (felbamate) is used very rarely. For people with severe epilepsy that is not well controlled by other seizure medicines, however, it may be worth considering, either alone or as an add-on. Before deciding to use Felbatol, read about the serious side effects here and ask your doctor or pharmacist for more extensive written information.

Doctors have studied people with partial seizures to find out how well Felbatol works. Studies have shown that Felbatol works well alone or when added to other seizure medicines. Felbatol is not a perfect add-on seizure medicine for everyone, however. Sometimes people must try a series of combinations before finding what is best for them. Some other medicines affect how Felbatol is eliminated from the body, and Felbatol may affect the levels of other seizure medicines, so the dosages may need to be changed with different combinations.

Studies have shown that Felbatol is also effective when added to other seizure medicine for partial and generalized seizures in children with Lennox-Gastaut syndrome.

What are the most common side effects of Felbamate?

Many people who take Felbatol don't report any unwanted side effects. Those who experience undesirable effects most often complain of:

decreased appetite and weight loss

nausea

insomnia (sleeplessness)

headache

Some other side effects were:

poor coordination or tremor (shaking)

vision problems

dizziness

vomiting

mood changes or anxiety

sleepiness (when given in combination with other seizure medicines)

If you notice any of these problems, call the doctor's office. Sometimes the doctor can help by changing the amount of Felbatol you take or how you take it. Don't stop taking Felbatol or change the amount you take without the doctor's guidance.

People who have just started taking Felbatol (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.

IMPORTANT

Serious blood and liver problems have occurred in a small number of people taking Felbatol. In some cases, these people died. Be sure to read about the serious side effects so you will be aware of symptoms that might indicate the beginning of one of these problems.

Allergic reactions

A rash occurs in a small number of people who take Felbatol. This reaction usually occurs within the first few weeks of treatment. Contact your doctor if a rash develops.

What are the most serious side effects of Felbamate?

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10.

Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;

Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;

Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.

Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:

Talking or thinking about wanting to hurt yourself or end your life

Withdrawing from friends and family

Becoming depressed or having your depression get worse

Becoming preoccupied with death and dying

Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Impact of Felbamate on bone health

At this time there is no evidence to support this medication causes bone health problems. However, it might. It is essential that if you taking this medication, that one take supplemental calcium of 1000 milligrams per day. Talk to your doctor about bone health. He/She may decide to check Vitamin D levels and other tests to check for the impact of this drug on your bones.

What else is Felbamate used for?

Often doctors find that medicines are useful for more than one purpose. It is legal to prescribe medicines for "off-label uses" even though the FDA has not formally approved such use. Because of the significant risk of serious side effects with Felbatol, there is no off-label use.

Who should not take Felbamate?

Before deciding to use Felbatol, read about the serious side effects here and ask your doctor or pharmacist for more extensive written information.

Everyone considering the use of Felbatol should read the box warning in the package insert and discuss the risk of life-threatening blood and liver disorders with their doctor.

People who are allergic to felbamate or to other medicines in the same family, called carbamates, should not take Felbatol. Neither should people who have had any liver disease, blood disorder, or problem with their immune system.

Can Felbamate be taken with other medicines?

Sometimes one kind of medicine changes the way another kind of medicine works in the body. If two kinds of medicine affect each other, the doctor may prescribe something else or change the amount to be taken.

How does Felbatol affect other medicines?

Felbatol makes birth control pills less effective, so the chances of becoming pregnant are greater. Women who use pills for birth control should talk to the doctor who prescribed them right away if they start taking Felbatol. The same is true for some other forms of birth control such as Depo-Provera or implants. Felbatol does not affect barrier types of birth control, like condoms, IUDs, and diaphragms.

Felbatol affects the way the body handles many other medicines. If you take Felbatol and another seizure medicine, the dosage of the other medicine may need to be adjusted.

For example, taking Felbatol may increase the level of these seizure medicines in the blood:

Dilantin or Phenytek (phenytoin)

carbamazepine-epoxide (the breakdown product of Tegretol, Tegretol XR and Carbatrol)

phenobarbital

Depakote and other valproate medicines (Depakene, valproic acid)

How do other medicines affect Felbatol?

Your body gets rid of Felbatol quicker if you are also taking certain seizure medicines, such as:

Dilantin or Phenytek (phenytoin)

Tegretol, Tegretol XR, or Carbatrol (carbamazepine)

phenobarbital

What are the effects of Felbamate on Children?

Before deciding to use Felbatol, read about the serious side effects here and ask your doctor or pharmacist for more extensive written information.

Felbatol is used to treat children with partial seizures either by itself or in combination with other seizure medicines. It is also used in combination with other seizure medicines for seizures in children with Lennox-Gastaut syndrome.

Doctors figure out how much medicine to give to young children based mostly on their weight. To keep side effects at a minimum, the doctor probably will prescribe a low dose to start with and increase it slowly. For Lennox-Gastaut syndrome, Felbatol should be started at 15 milligrams (mg) per kilogram (kg, about 2.2 pounds) of body weight per day. This amount is divided into three or four doses. The dosage of Felbatol is increased by 15 mg per kg per day at weekly intervals until seizures are brought under control or unacceptable side effects occur. A typical ongoing dose is 45 mg per kg per day.

If the liquid suspension is used, it is very important to thoroughly shake the bottle immediately before measuring. A child who gets a dose from a bottle that has not just been well shaken may get too much or too little medication.

If a woman takes Felbamate during pregnancy will it hurt the baby?

Before deciding to use Felbatol, read about the serious side effects here and ask your doctor or pharmacist for more extensive written information.

In the United States, the Food and Drug Administration (FDA) assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Trileptal is listed in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medicine may outweigh the potential risks. Studies in animals have shown some harm to the baby, but there haven't been any good studies of results in women.

Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if Felbatol is taken during pregnancy. We also don't know enough to compare the risk with Felbatol to the risk with other seizure medicines. The risk of birth defects is generally higher for women who take more than one seizure medicine and for women with a family history of birth defects.

Women who are capable of becoming pregnant should take at least 400 mcg (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant.

How much Felbatol is passed through breast milk is not known for certain. If you want to breast-feed your baby, check with your doctor.

What are the effects of Felbamate on Seniors

Before deciding to use Felbatol, read about the serious side effects here and ask your doctor or pharmacist for more extensive written information.

Considering the large number of safer seizure medications, Felbatol is very rarely used in seniors. When it is used, the dosage is lower than for young adults.

Seniors may be more sensitive to the side effects of Felbatol. Another difficulty with the use of Felbatol in seniors is its potential for interactions with other medicines.

What are the dose ranges for Felbamate?

The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual. Follow the doctor's directions. Call if you have any questions.

In young adults, Felbatol is usually started at 600 to 1,200 milligrams (mg) per day in 3 to 4 divided doses. Every 7 to 14 days, the amount can be increased by 600 to 1,200 mg per day if needed (if side effects are not troublesome), to a maximum dose of 3,600 mg day in 3 to 4 divided doses.

In children over 6, the daily starting dose is 15 mg per kilogram (kg, about 2.2 pounds) of body weight, given in 3 or 4 divided doses. The usual ongoing dose is 15 to 45 mg per kg per day, usually in 3 or 4 divided doses.

Special Concerns for Felbamate

See package insert.

Read the package insert of Felbamate

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Felbatol is found at: